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Effects of Craniocervical Muscles Dry Needling on Somatosensory Tinnitus Symptoms: A Double Blind Randomized Controlled Trial

Protocol summary

Study aim
to investigate the effect of craniocervical muscles dry needling on symptomps of somatosensory tinnitus
Design
24 patients are divided into two groups of intervention (therapeutic dry needling) and control (placebo dry needling) using simple randomization method through sealed envelopes. The study is double-blinded.
Settings and conduct
One of the common causes of somatosensory tinnitus is the trigger points in the head ,neck and TMJ. The current study intends to investigate the effect of dry needling (with the aim of deactivating these points) on the symptoms of these patients. The study will be double-blinded (participant, accessor, analyst) and coding to the evaluation forms will be used for blinding.
Participants/Inclusion and exclusion criteria
inclusion criteria: patients suffering from tinnitus since 3 months ago, patients with Sanchez, Levin, and Michiel criterion, patients with trigger points in head, neck and shoulder girdle, normal audiometry. Exclusion criteria: patients with contraindications to the use of needles such as fear of needles, history of using anti-inflammatory drugs and manual therapy in the 30 days before the evaluation, experience of using dry needling in the target area, any symptoms indicating that tinnitus is otological, unwillingness To cooperate
Intervention groups
In the intervention group, therapeutic dry needling will be performed to deactivate the trigger points of the targeted muscle based on the Damerhold approach. In the control group, dry needling will be used as a placebo.
Main outcome variables
Tinnitus annoyance, tinnitus loudness, head and neck and TMJ muscle pain, pressure pain threshold, neck range of motion, TMJ range of motion, degree of disability due to tinnitus, degree of disability due to neck pain, degree of disability due to TMJ disorder

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240323061355N1
Registration date: 2024-08-01, 1403/05/11
Registration timing: registered_while_recruiting

Last update: 2024-08-01, 1403/05/11
Update count: 0
Registration date
2024-08-01, 1403/05/11
Registrant information
Name
Kiarash Namiranian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7787 9709
Email address
k-namiranian@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-22, 1403/05/01
Expected recruitment end date
2025-01-20, 1403/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Craniocervical Muscles Dry Needling on Somatosensory Tinnitus Symptoms: A Double Blind Randomized Controlled Trial
Public title
Effect of Dry Needling on Muskuloskeletal Tinnitus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients of both sexes with unilateral or bilateral tinnitus and at least 3 months have passed since the onset of symptoms. Existence of Sanchez, Levine and Michiel criteria to determine somatic tinnitus The presence of at least one Latent or active trigger point in the head and neck and shoulder girdle Normal audiometry
Exclusion criteria:
Having contraindications for using needles such as fear of needles, lymphedema in the region, Vascular and blood diseases, use of blood thinners such as warfarin Taking pain-reducing drugs such as anti-inflammatories and muscle relaxants in the 30 days before the evaluation Fibromyalgia Having previous experience of using dry needling technique in the head, neck and shoulder girdle region Manual therapy to reduce pain in the craniocervical region in the 30 days prior to evaluation Occurrence of symptoms that indicate that the patient's tinnitus symptoms are otological, such as sudden deafness, infection of ear, damage to the eardrum and suffering from diseases such as Meniere's, perilymphatic fistula, etc. The presence of abnormal posture in the head and neck region caused by neurological lesions The patient's unwillingness to continue the treatment and cooperate in the research
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 24
Randomization (investigator's opinion)
Randomized
Randomization description
At this stage, with the help of physiotherapist 1 (evaluator), participants are randomly selected through the sealed envelope method.The sealed letters are divided into 2 intervention and control groups. For this purpose, 24 envelopes are prepared, which are filled with the numbers 1 and 2 (12 envelopes containing the number 1 and 12 envelopes containing the number 2). The numbers 1 and 2 each Separately means entering one of the intervention and control groups, which only the physiotherapist 2 (therapist) knows about it. Before choosing the envelope by the patient, we will change the order of the envelopes several times and after choosing the envelope by The patients, number is recorded on the evaluation sheet. In both groups, three treatment sessions will be performed every other day.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study will be double-blinded. in this way, the participants do not know which study group they are in. Another physiotherapist will do the basic and post-treatment evaluations without knowing which patients belonged to which groups (assessor-blinded). Also, the data analyst is not aware of which group the data belongs to.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Amir A'lam Hospital Complex
Street address
Amir A'lam Hospital Complex, SAADI Street
City
Tehran
Province
Tehran
Postal code
1145765111
Approval date
2024-03-10, 1402/12/20
Ethics committee reference number
IR.TUMS.AMIRALAM.REC.1402.053

Health conditions studied

1

Description of health condition studied
Somatosensory Tinnitus
ICD-10 code
H93.19
ICD-10 code description
Tinnitus, unspecified ear

Primary outcomes

1

Description
Tinnitus Annoyance
Timepoint
Before intervention, After the 1th intervention session, After the 3rd intervention session, 1 week After the last session
Method of measurement
visual analogue scale

2

Description
Tinnitus Loudness
Timepoint
Before intervention, After the 1th intervention session, After the 3rd intervention session, 1 week After the last session
Method of measurement
Visual Analogue Scale

3

Description
The amount of pain in the muscles of the head and neck, upper thoracic and TMJ
Timepoint
Before intervention, After the 1th intervention session, After the 3rd intervention session, 1 week After the last session
Method of measurement
Visual Analogue Scale

4

Description
Pain Pressure Threshold
Timepoint
Before intervention, After the 1th intervention session, After the 3rd intervention session, 1 week After the last session
Method of measurement
Digital Algometer

Secondary outcomes

1

Description
The range of motion of the neck in direction of flexion, extension, lateral flexion and rotation actively
Timepoint
Before intervention, After the 1th intervention session, After the 3rd intervention session, 1 week After the last session
Method of measurement
Goniometer

2

Description
The range of motion of the temporomandibular joint in the directions of depression, elevation, protrusion, retrogression, lateral extrusion actively
Timepoint
Before intervention, After the 1th intervention session, After the 3rd intervention session, 1 week After the last session
Method of measurement
Ruler

3

Description
Quality of life and degree of functional disability caused by tinnitus
Timepoint
Before intervention, After the 3rd intervention session, 1 week After the last session
Method of measurement
Tinnitus Handicap Inventory

4

Description
Quality of life and degree of functional disability caused by neck pain
Timepoint
Before intervention, After the 3rd intervention session, 1 week After the last session
Method of measurement
Neck Disability Index

5

Description
Quality of life and functional disability caused by temporomandibular joint disorder
Timepoint
Before intervention, After the 3rd intervention session, 1 week After the last session
Method of measurement
Fonseca Anamnestic Questionnaire

Intervention groups

1

Description
Intervention group: Group A: Will recieve dry needling therapy based on Damerhold approach for three sessions every other day at the trigger points site.
Category
Rehabilitation

2

Description
Control group: Group B:Control group Will receive dry needling as a placebo for three sessions every other day at the trigger points site
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Amir A'alam hospital
Full name of responsible person
Nastaran Ghotbi
Street address
Saadi street, Enghelab street
City
Tehran
Province
Tehran
Postal code
1145765111
Phone
+98 21 6672 7060
Email
nghotbi@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Sari
Street address
Vice Chancellor for Research and Technology, Sixth floor, Central University Organization, Corner of Quds Street, Keshavarz Bouulevard
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3639
Email
research@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Kiarash Namiranian
Position
MSc Candidate
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Piche-Shemiran, Enghelab Street
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7752 8468
Email
k-namiranian@razi.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nastaran Ghotbi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Piche- Shemiran, Enghelab Street
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
009877528468
Email
nghotbi@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Kiarash Namiranian
Position
MSc Candidate
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Piche-Shemiran, Enghelab Street
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7752 8468
Email
k-namiranian@razi.tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data is potentially shaeable after unidentified individuals
When the data will become available and for how long
َشروع دوره دسترسی 3 ماه پس از چاپ مقالات
To whom data/document is available
For researchers working in academic, scientific and hospital institutions
Under which criteria data/document could be used
Researchers working in the field of vestibular and orthopaedic Physicaltherapy
From where data/document is obtainable
Applicants for documentation can contact Dr. Nastaran Ghotbi via Email nghotbi@tums.ac.ir
What processes are involved for a request to access data/document
Once they have the necessary criteria, information will be provided to them within a month
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